The purpose of the protocol is to assess the responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale following one botulinum toxin type-A (BoNT-A) injection cycle in accordance with routine practices.

A National, Prospective Cohort to Document the Effectiveness of One BoNT-A Injection Cycle Based on Attainment of Individual Person-centred Goals in Adult Subjects Suffering From Lower Limb Spasticity Following Stroke

Further study details as provided by Ipsen:

Primary Outcome Measures:

Responder rate as defined by the achievement of the primary goal from the Goal Attainment Scale (GAS). [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]

Assessed using the Goal Attainment Scale (GAS).

Secondary Outcome Measures:

Overall attainment of treatment goals [ Time Frame: Between 1 and 3 months from inclusion ] [ Designated as safety issue: No ]

Assessed using the GAS T-Score.

The use of standardized outcome measures and their results (e.g. muscle tone reduction, pain scores, functional tests). [ Time Frame: Up to 5 months ] [ Designated as safety issue: No ]

With at least a 12-week interval between the last BoNT-A injection and inclusion

Decision already been agreed to inject BoNT-A

Exclusion Criteria:

Documented positive antigenicity to botulinum toxin

Any neuromuscular junction indication

Severe muscle atrophy in any muscle to be injected

Any other indication that might interfere with rehabilitation or the evaluation of results

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01444794